IRLAB Therapeutics — Next steps laid out for IRL757

IRLAB Therapeutics (OMX: IRLAB-A)

Last close As at 29/03/2025

SEK8.44

1.46 (20.92%)

Market capitalisation

SEK362m

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Research: Healthcare

IRLAB Therapeutics — Next steps laid out for IRL757

IRLAB has confirmed that clinical candidate IRL757, which has been designed to address apathy in patients with neurodegenerative conditions, will proceed to the next stages of clinical development. The next step will be a safety and efficacy signal finding Phase Ib trial in patients with Parkinson’s disease (PD), which will be financially supported by IRLAB’s collaboration partner, the McQuade Center for Strategic Research and Development (MSRD) through an initial payment of US$4.5m. The company expects patient enrolment for this Phase Ib study to commence in H225. We note that the decision to advance this programme was based on data from the preceding two Phase I studies for IRL757 and believe that the external recognition highlights the potential of IRLAB’s third clinical candidate.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

IRLAB Therapeutics_resized

Healthcare

Clinical update

27 March 2025

Price SEK6.62
Market cap SEK361m

SEK10.05/US$

Net cash/(debt) at 31 December 2024 (including lease liabilities)

SEK6.5m

Shares in issue

51.8m
Free float 61.5%
Code IRLABA
Primary exchange OMX
Secondary exchange N/A
Price Performance

Business description

Based in Sweden, IRLAB Therapeutics is focused on developing novel drugs for the treatment of neurodegenerative diseases utilising its ISP technology platform. Its two lead assets are in late-stage clinical trials for the symptomatic treatment of Parkinson’s disease: mesdopetam (D3 antagonist) and pirepemat (PFC enhancer).

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

IRLAB Therapeutics is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Year end Revenue (SEKm) PBT (SEKm) EPS (SEK) DPS (SEK) P/E (x) Yield (%)
12/23 5.7 (177.8) (3.43) 0.00 N/A N/A
12/24 114.1 (83.1) (1.60) 0.00 N/A N/A
12/25e 20.9 (145.0) (2.80) 0.00 N/A N/A
12/26e 32.6 (144.0) (2.78) 0.00 N/A N/A

According to the announcement, IRLAB will be progressing IRL757 to the next stages of clinical development, with the backing of a US$4.5m initial payment from MSRD in the current quarter. While IRL757 has the potential to address apathy in a range of neurodegenerative conditions like Alzheimer's disease, the decision to include PD patients at this stage in the Phase Ib safety and efficacy signal finding trial is logical, given that the indication is the main focus of IRLAB’s clinical development pipeline. Prior clinical studies for IRL757 include two Phase I trials: one in healthy younger volunteers (supported by the Michael J Fox Foundation (MJFF) through a US$2m grant) and one in healthy adults aged 65 years and older (supported by MSRD). The latter concluded in January 2025, reporting positive top-line results, showing favourable safety and tolerability outcomes and a favourable pharmacokinetic profile, supporting subsequent development efforts. The MJFF-sponsored study reported encouraging interim results in October 2024, and we understand that this is expected to conclude in Q125. In our view, the collaborations with MSRD and the MJFF serve as external validation of IRL757’s potential to address apathy, a condition for which there are currently no FDA-approved drugs.

IRLAB’s two other clinical-stage candidates are pirepemat (to improve balance and reduce falls in PD, PD-Falls) and mesdopetam (to address levodopa-induced dyskinesias in PD, PD-LIDs). In March 2025, IRLAB reported that pirepemat did not meet the primary and secondary endpoint of its Phase IIb trial, driven by a notably strong placebo effect; management is conducting a detailed analysis of the data to assess potential next steps. Mesdopetam is Phase III-ready for PD-LIDs, with positive endorsements from both the FDA and EMA. Subject to securing a suitable partner, a Phase III programme could be launched in 2025.

Following recent new financing, we estimate that IRLAB is funded unto Q425.

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